Recall Z-3259-2026
New York Embroidery Studio, Inc. · initiated July 31, 2026
Product
New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large. Model Number: NYES100-2. Packaged in inner packs of 10 and 100 gowns per shipping case.
Codes / lots: Model #: NYES100-02. Primary DI00860008955142. UDI-DI: 10860008955149. Lot Number: B0676.
Reason for recall
Gowns do not consistently meet the minimum liquid-barrier performance required.
FDA-determined cause: Process control
Action taken
New York Embroidery Studio (NYES) notified the single consignee via email on 07/31/2026. The consignee was instructed to identify and remove from available inventory the three affected pallets containing Lot B0676, process the product out of inventory, segregate and ship all affected product for return to NYES.
Details
- Recall number
- Z-3259-2026
- Initiated
- July 31, 2026
- Posted by FDA
- September 23, 2026
- Product code
- OEA – Non-Surgical Gown
- Quantity
- 5,400 gowns
- Distribution
- US Nationwide distribution in the state of Connecticut.
- Recalling firm
- New York Embroidery Studio, Inc.